U.S. patent application number 09/823536 was filed with the patent office on 2001-11-29 for method and apparatus for making fluid delivery device.
Invention is credited to Kriesel, Marshall S..
Application Number | 20010046573 09/823536 |
Document ID | / |
Family ID | 25086131 |
Filed Date | 2001-11-29 |
United States Patent
Application |
20010046573 |
Kind Code |
A1 |
Kriesel, Marshall S. |
November 29, 2001 |
Method and apparatus for making fluid delivery device
Abstract
A method and apparatus for the high volume manufacture of fluid
infusion devices which embody a self-contained, stored-energy
source for expelling fluids from the reservoir of the device into
an ambulatory patient at precisely controlled rates over extended
periods of time. In accordance with the method of the invention,
the base and cover infusion components of the devices of the
invention are manufactured in injection molded arrays which
comprise a cover array which is superimposed over and connected to
a base array with the elastomeric membrane being captured
therebetween. The elastomeric membrane material, which forms the
stored-energy source of the infusion devices, is continuously
unrolled from a large roll of film-backed membrane material which
is rotatably mounted on a turret assembly upon which a second
back-up roll of elastomeric membrane material is also mounted.
After being unrolled, the film backing is separated from the
membrane and the membrane is introduced into a novel tenter
apparatus which controllably, biaxially stretches the membrane
material. Following the stretching step, the membrane is
automatically cut and then sealed between the cover components and
base components of the cover and base arrays. The finished,
individual infusion devices are then separated from the arrays and
automatically packaged for shipping.
Inventors: |
Kriesel, Marshall S.; (St.
Paul, MN) |
Correspondence
Address: |
James E. Brunton
P.O. Box 29000
Suite 860
700 North Brand Blvd.
Glendale
CA
91029
US
|
Family ID: |
25086131 |
Appl. No.: |
09/823536 |
Filed: |
March 30, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09823536 |
Mar 30, 2001 |
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09250034 |
Feb 12, 1999 |
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6209608 |
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09250034 |
Feb 12, 1999 |
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08769654 |
Dec 19, 1996 |
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5906703 |
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Current U.S.
Class: |
428/34.1 |
Current CPC
Class: |
B29C 55/165 20130101;
Y10T 156/1759 20150115; Y10T 156/1756 20150115; Y10T 428/13
20150115 |
Class at
Publication: |
428/34.1 |
International
Class: |
B32B 001/02 |
Claims
I claim:
1. An array comprising: (a) a base array comprising a plurality of
adjacent base components, each said base component being
interconnected with an adjacent base component and each having an
upper surface; (b) an elastomeric membrane covering said upper
surface of each said base component; and (c) a cover array
comprising a plurality of adjacent cover components, each said
cover component being interconnected with an adjacent cover
component, said cover array being interconnected with said base
array to form a plurality of sealably interconnected together base
components and cover components each having an elastomeric membrane
captured therebetween.
2. An array as defined in claim 1 in which said sealably
interconnected base components and cover components are
interconnected together by bonding.
3. An array as defined in claim 1 in which each said base component
includes an outwardly extending cannula having a fluid inlet and a
fluid outlet and a cannula body portion disposed between said fluid
inlet and said fluid outlet.
4. An array as defined in claim 3 in which each said base component
includes a base having a cavity formed therein and in which said
body portion of said cannula is disposed within said cavity.
5. An array as defined in claim 4 in which each said cannula is
generally spiral shaped.
Description
[0001] This is a Divisional Application of co-pending application
Ser. No. 09/250,034 which is a Divisional of application Ser. No.
08/769,654, now U.S. Pat. No. 5,906,703.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates generally to methods and
apparatus for making fluid delivery devices for infusing medicinal
agents into an ambulatory patient at specific rates over extended
periods of time. More particularly, the invention concerns a novel
method and apparatus for the large volume manufacture of small,
disposable fluid delivery devices for infusion of medicinal agents
into a ambulatory patient.
[0004] 2. Discussion of the Prior Art
[0005] Many medicinal agents require an intravenous route for
administration thus bypassing the digestive system and precluding
degradation by the catalytic enzymes in the digestive tract and
liver. The use of more potent medications at elevated
concentrations has also increased the need for accuracy in
controlling the delivery of such drugs. The delivery device, while
not an active pharmacologic agent, may enhance the activity of the
drug by mediating its therapeutic effectiveness. Certain classes of
new pharmacologic agents possess a very narrow range of therapeutic
effectiveness, for instance, too small a dose results in no effect,
while too great a dose results in toxic reaction.
[0006] In the past, prolonged infusion of fluids has generally been
accomplished using gravity flow methods, which typically involve
the use of intravenous administration sets and the familiar bottle
suspended above the patient. Such methods are cumbersome, imprecise
and require bed confinement of the patient. Periodic monitoring of
the apparatus by the nurse or doctor is required to detect
malfunctions of the infusion apparatus.
[0007] The fluid delivery devices made in accordance with the
method of the present invention overcome many of the drawbacks of
the prior art by making use of advanced types of prestressed
elastomeric films which, in cooperation with a base, define a fluid
chamber that contains the fluid which is to be dispensed. The
prestressed elastomeric film membrane, which is further distended
during the filling of the fluid chamber, controllably forces fluid
within the chamber outwardly of the device as the membrane moves
toward its less distended stating configuration.
[0008] The elastomeric film materials used in the fluid delivery
devices manufactured in accordance with the methods of the present
invention, as well as various alternate constructions of the fluid
delivery devices themselves, are described in detail in U.S. Pat.
No. 5,205,820 issued to the present inventor. Therefore, U.S. Pat.
No. 5,205,820 is hereby incorporated by reference in its entirety
as though fully set forth herein. Co-pending U.S. Ser. No.
08/451,520 filed by the present inventor on May 26, 1995 also
describes several alternate constructions of fluid delivery devices
that can be manufactured in accordance with the teachings of the
present invention. This co-pending application, which also
discloses an apparatus for making fluid delivery devices on an
individual basis, is also hereby incorporated by reference in its
entirety as though fully set forth herein.
[0009] As will be better appreciated from the discussion which
follows, the methods and apparatus of the present invention are
ideally suited for the large-scale manufacture of fluid delivery
devices of the character described herein and in application Ser.
No. 08/451,520. These delivery devices typically comprise a base
assembly and a stored energy means provided in the form of a thin,
prestressed, distendable, elastomeric membrane which after being
cut in a manner described in Ser. No. 08/451,520, cooperates with
the base assembly to form a fluid reservoir. Contained within a
cavity formed in the base assembly is circuitously shaped, hollow
cannula which includes an inlet in communication with the fluid
reservoir and an outlet formed in a needle-like segment, which
extends generally perpendicularly downward from the lower surface
of the base assembly for subdermal infusion of medicinal fluids
into the patient.
[0010] The novel fluid delivery devices manufactured in accordance
with the present invention have an extremely low profile and are
eminently capable of meeting the most stringent of fluid delivery
tolerance requirements. The devices are small, easy to use and, in
accordance with the method of the present invention, can be
manufactured in very large quantities at low cost.
SUMMARY OF THE INVENTION
[0011] It is an object of the present invention to provide a method
and apparatus for the high volume manufacture of fluid delivery
devices which embody a self-contained, stored-energy source for
expelling fluids from the reservoir of the device into an
ambulatory patient at precisely controlled rates over extended
periods of time.
[0012] It is another object of the invention to provide a method
and apparatus of the aforementioned character in which the
self-contained, stored-energy source comprises an elastomeric
membrane and in which the fluid dispensing devices are manufactured
in arrays each array comprising a cover array which is superimposed
over and connected to a base array with the elastomeric membrane
being captured therebetween.
[0013] Another object of the invention is to provide an apparatus
for the continuous assembly of fluid delivery devices of the
character described in the preceding paragraphs in which the
elastomeric membrane material which forms the stored-energy source
is continuously unrolled from a large roll of film-backed material
which is rotatably mounted on a turret assembly upon which a second
back-up roll of elastomeric membrane material is also mounted.
[0014] Another object of the invention is to provide an apparatus
of the character described in the immediately preceding paragraph
which further includes membrane splicing means for splicing
together the end of the primary roll and the beginning of back-up
roll of the rolls mounted on the turret assembly.
[0015] Another object of the invention is to provide an apparatus
as described which includes a novel tenter apparatus for
controllably, biaxially stretching the membrane material following
its removal from the rolls of membrane material carried by the
turret assembly.
[0016] Another important object of the invention is to provide a
method and apparatus of the character described in which, without
interrupting the forward travel of the biaxially stretched,
elastomeric membrane, the membrane is automatically sealably
captured between the cover and base arrays.
[0017] Another object of the invention is to provide a method and
apparatus of the class described in which, following assembly of
the various components of the infusion devices, the finished
devices are automatically labeled and packaged for shipment.
DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 is a generally perspective view of a cover array
comprising a plurality of individual covers of the fluid delivery
devices which are to be produced in accordance with the method of
the present invention.
[0019] FIG. 2 is a generally perspective view of a base array
comprising a plurality of base assemblies of the fluid delivery
devices which are to be produced in accordance with the method of
the invention.
[0020] FIG. 3 is a generally perspective view similar to FIGS. 1
and 2, but showing a length of biaxially stretched, elastomeric
membrane disposed intermediate the cover and base arrays.
[0021] FIG. 3A is a generally perspective view showing the
appearance of the array of fluid delivery devices constructed by
sealably bonding together the base, the cover and elastomeric
membrane components shown in FIG. 3.
[0022] FIG. 4 is a generally perspective view of one of the
individual fluid delivery devices of the array shown in FIG. 3A
after being separated from the connecting sprues.
[0023] FIG. 4A is a side-elevational, cross-sectional view of the
individual fluid delivery device shown in FIG. 4 and produced in
accordance with the method of the invention.
[0024] FIG. 4B is a generally perspective, exploded view of the
device shown in FIG. 4.
[0025] FIGS. 5A, 5B, and 5C when considered together in the manner
illustrated in FIG. 5D, comprise a side-elevational view of one
form of the apparatus of the present invention for the continuous
assembly of the various components of the fluid delivery device
shown in FIG. 4. More particularly, FIG. 5A shows the operator
control portion of the apparatus along with the support means for
rotatably supporting primary and back-up rolls of elastomeric
membrane from which the energy source of the fluid dispensing
device of FIG. 4A is formed and the lower array input feeder. FIG.
5B illustrates the splicer subassembly, the tension dancer arm, the
membrane accumulator subassembly; membrane stretching means of the
apparatus of the invention for controllably stretching the
elastomeric membrane to form a prestressed membrane having internal
stresses formed therewithin. Also shown in FIG. 5B is a portion of
the upper and lower in feed array assemblies, a portion of the
array take-off assembly, the sealing means and a portion of the
over and under walking beam assembly of the invention for sealably
interconnecting the cover components of the cover array shown in
FIG. 1 with the base components of the base array shown in FIG. 2.
FIG. 5C is a side-elevational view showing portions of the
positioning means for positioning the cover array with respect to
the sealing means of the invention. Also illustrated in FIG. 5C is
one form of the upper array input assembly, the array take-off
assembly and the packaging, labeling and sealing portion of the
apparatus for final packaging of the fluid dispensing devices
produced in accordance with the method of the invention.
[0026] FIGS. 6A, 6B, and 6C when considered together, comprise a
top plan view of the apparatus of the invention shown in FIGS. 5A,
5B, and 5C.
[0027] FIGS. 7A, 7B, and 7C when considered together, comprise a
generally perspective view of the apparatus of the invention shown
in FIGS. 5A, 5B, and 5C.
[0028] FIG. 7D is a generally perspective, fragmentary view similar
to FIG. 7A, but showing in greater detail the support means of the
invention for supporting the rolls of elastomeric membrane
material. Also shown in greater detail is the splicing means of the
invention for splicing together lengths of elastomeric membrane and
also showing in greater detail the dancer arm assembly of the
invention which monitors and maintains proper speed and tension on
the elastomeric membrane as it advances forwardly of the apparatus.
Further shown is the membrane accumulator assembly of the
invention.
[0029] FIGS. 7E and 7F, when considered together, comprise a
fragmentary, generally perspective view showing in greater detail
the membrane stretching means or tenter apparatus of the invention
also shown in FIG. 7B.
[0030] FIG. 8 is an end view of the right end of the apparatus of
the invention as viewed in FIG. 6C.
[0031] FIG. 9 and FIG. 9A, when considered together in the manner
illustrated in FIG. 9B, comprise a fragmentary, generally
perspective view of the upper array input assembly of the
apparatus.
[0032] FIG. 10 is a fragmentary, generally perspective view of the
reciprocating assembly shuttle which cooperates with the sonic
bonding means of the apparatus to bond together the cover and base
components.
[0033] FIG. 11 is a fragmentary, generally perspective view of the
lower array input assembly.
[0034] FIG. 12 is a generally diagrammatic, perspective view
illustrating the position of the various subassemblies of the
component assembly apparatus of the invention as they appear at the
start of an assembly sequence.
[0035] FIG. 13 is a generally schematic, perspective view similar
to FIG. 12, but showing the position of the subassemblies as they
appear at an interim step of the assembly process.
[0036] FIG. 14 is a generally diagrammatic, perspective view
illustrating the position of the cooperating subassemblies of the
apparatus during the bonding step wherein the cover components are
bonded to the base components.
[0037] FIG. 15 is a generally diagrammatic, perspective view
illustrating the position of the subassemblies of the apparatus
following completion of the bonding step and prior to the
commencement of the packaging operation.
[0038] FIGS. 16 and 16A, when considered together in the manner
illustrated in FIG. 16B, comprise a generally diagrammatic,
perspective view illustrating the position of the subassemblies of
the apparatus at the commencement of the final packaging step.
DESCRIPTION OF THE INVENTION
[0039] Referring to the drawings and particularly to FIGS. 4 and
4A, one embodiment of the infusion device produced in accordance
with the method of the invention is there shown and generally
designated by the numeral 14. As best seen in FIG. 4A, the infusion
device, which functions to controllably infuse medicinal agents
into an ambulatory patient, comprises a base component or
assemblage 16 which includes a base member 16a. Base member 16a has
an upper surface 18, which includes a central portion 18a, and a
peripheral portion 18b. Formed within base member 16 is a cavity or
chamber 20, the purpose of which will presently be described.
[0040] Sealably interconnected with base component 16 is a cover
component 22 having a generally toroidal shaped cavity 24 formed
therein. Sealably captured between base component 16 and cover
component 22 is a prestressed elastomeric membrane 27. Membrane 27,
which comprises the stored energy source of the device, is
distendable by fluids under pressure introduced into the device
from a generally planar configuration into a distended
configuration of the character shown in FIG. 4A. When so distended,
membrane 27, in cooperation with the upper surface 18 of the base
component, forms a generally toroidal-shaped fluid chamber 30.
[0041] Also forming a part of base assembly 16 is cannula means for
controllably delivering fluid from reservoir 30 to an ambulatory
patient. The cannula means here comprises a generally spiral-
shaped, hollow cannula 32 having an inlet 34 in communication with
reservoir 30 and an outlet defined by a needle-like piercing
extremity 36. Disposed intermediate inlet 34 and outlet 36 is a
spiral body portion 38 which is supported within chamber 20 of the
base component.
[0042] With the cannula means appropriately mounted within chamber
20, a needle cap assembly 40 is connected to base 16a. Needle cap
assembly 40 here comprises a base portion 40a which is affixed to
base 16a and a sheath portion 40b which functions to encapsulate
the piercing extremity 36 of the cannula. Formed between base
portion 40a and sheath portion 40b is serration 40c which permits
the sheath portion to be broken away from the body portion at time
of use to expose extremity 36.
[0043] During use of the device and after the reservoir of the
apparatus has been filled with the appropriate beneficial agent to
be infused which causes membrane 27 to distend to the position
shown in FIG. 4A, the sheath of the needle cap assembly 40 can be
separated from the assemblage by breaking it along the serration
40c. This done, the device can be easily interconnected with the
patient by penetrating the patient's skin with the piercing
extremity 36 of the cannula means. As the patient's skin and tissue
is penetrated by the infusion needle, an adhesive pad 39 provided
on the lower surface of the base 16a will cause the base component
to adhere to the patient's skin. In some instances, it is desirable
to provide a protective peel layer over the adhesive pad until the
time the device is to be used. In such instances, the protective
layer is peeled from the lower surface of base 16a immediately
prior to use of the device.
[0044] With the infusion device securely interconnected with the
patient, and with the sheath 40b removed from the base component,
distendable membrane 27 will tend to return to its less distended
configuration due to the internal stresses formed in the membrane
during the reservoir filling step. As the distendable membrane
moves toward base 16a, the fluid contained within reservoir 30 will
flow into the patient at a precisely controlled rate. In this
regard, it is to be noted that elastomeric membrane materials
suitable for use as the stored energy means must possess certain
physical characteristics in order to meet the performance
requirements for a fluid delivery apparatus. More particularly, for
good performance, the elastomeric membrane material must have good
memory characteristics under conditions of high expansion; good
resistance to chemical and radiological degradation; and
appropriate gas permeation characteristics depending upon the end
application to be made of the device. Reference should be made to
application Ser. No. 08/451,520 which is incorporated herein by
reference for more details concerning the construction and
operation of the infusion device 14 including details concerning
the nature of the stored energy source, the cannula means, and the
protective needle cap assembly and for details concerning the
materials suitable for use in constructing the base and cover
components.
[0045] Turning next to FIGS. 1, 2, and 3, in accordance with one
form of the method of the invention, the infusion devices 14 are
produced in large volume by a continuous process whereby injection
molded base arrays and cover arrays of the character shown in FIGS.
1 and 2 of the drawings are sealably interconnected together using
the apparatus of the invention. One form of the cover array of the
invention is shown in FIG. 1 and designated by the numeral 44 while
one form of the base array of the invention is shown in FIG. 2 and
is designated by the numeral 46.
[0046] Cover array 44 comprises a plurality of adjacent cover
components 22 each of which is interconnected with an adjacent
cover component 22 by at least one sprue element 48. Similarly,
base array 46 comprises a plurality of adjacent base components 16
each of which is interconnected with an adjacent base component by
one or more sprue elements 50. As indicated in FIG. 1, the outer
sprue elements 48 are interconnected with a circumferentially
extending spruelike member 48a while the outer most sprue elements
50 of the base array are interconnected with a circumferentially
extending sprue-like element 50a (FIG. 2).
[0047] As will be discussed in greater detail hereinafter, during
the assembly of the cover and base arrays in accordance with one
form of the method of the invention, the cover array is
superimposed over the base array with the elastomeric membrane 27
disposed therebetween in the manner shown in FIG. 3. In accordance
with the method of the invention, the cover components 22 and the
base components 16 are then interconnected and sealably bonded
together to form the product array shown in FIG. 3A and generally
designated by the numeral 54. Product array 54 comprises a
plurality of interconnected together, fully assembled fluid
delivery devices of the character previously described, each having
a cover component 22, a base component 16 having a downwardly
extending cannula assembly, including a protective sheath 40, and a
portion of the prestressed elastomeric membrane 27 captured
therebetween. In accordance with the method of the invention,
following the assembly operation, the assembled fluid delivery
devices 14 are separated from the sprue members 50 to form a
plurality of individual final product, fluid dispensing devices of
the general character illustrated in FIG. 4. The specific details
of the novel method of the invention whereby the cover components
and the base components are sealably interconnected to form the
array shown in FIG. 3A will be discussed further in the paragraphs
which follow
[0048] Turning next to FIGS. 5A, B, and C; 6A, B, and C; and 7A, B,
and C, one form of the apparatus of the present invention for
continuous assembly of the various components of the fluid delivery
device 14 is there shown. Turning particularly to FIGS. 5A and B,
6A and B, and 7A and 8, the operator control means and part of the
support means of one form of the apparatus of the invention is
there shown. The control means for controlling and monitoring the
various component assembly mechanisms of the apparatus is generally
designated as 60 in FIGS. 5A, 6A and 7A, and 7B and C. Means 60
here comprises a systems control monitor 62, an operations monitor
64, an operator keyboard input station 66, and an operator data
tablet input station 68. For convenience, these operably
interconnected monitoring and input devices are mounted in a mobile
framework 70 of the character shown in FIGS. 5A, 6A, and 7A.
Control means 60 is constructed from conventional, commercially
available devices of a character well known to those skilled in the
art, and the interconnection and operation of these devices is well
understood.
[0049] Shown in the right-hand portions of FIGS. 5A, and 6A and in
all of FIGS. 5B and C; 6B and C; and 7B and C are the various
cooperating subassemblies which make up the component assembly
means of the invention for assembling together the several
components which make up the fluid delivery device 14. These
subassemblies are mounted within an elongated framework 71 having a
first end 71a and a second end 71b.
[0050] The first subassembly of the component assembly means of the
invention consists of a novel support means of the character shown
in the right-hand portions of FIGS. 5A, 6A, and 7A and the
left-hand portions of FIGS. 5B, 6B, and 7B. The important support
means of the invention functions to rotatably support primary and
back-up rolls 72 and 74 of film-backed lengths of elastomeric
material. As best seen in FIGS. 5A, 7B and 7D, rolls 72 and 74 are
mounted on a novel turret assembly 76 which is supported proximate
the first end 71a of the supporting framework 71 and includes a
turret plate 78 that can be controllably rotated about a central
rotational axis 80. Mounted on plate 78 is a pair of spaced apart
spindles 82 and 84. Spindle 82 rotatably supports back-up roll 72
while spindle 84 rotatably supports primary roll 74. A loading
means, best seen in FIGS. 5A, 5B, 7B and 7D, is provided in the
form of a roll loading subassembly 86, including a lift mechanism
86a, which can be used to conveniently load the film-backed rolls
of elastomeric material onto spindles 82 and 84.
[0051] In carrying out the method of the invention, the driving
motors of the various operating mechanisms of the apparatus are
energized using a control panel 75 of conventional construction.
When the mechanisms are operating, a warning light 75a is
illuminated. As an initial step, the elastomeric membrane is
removed from roll 74 by the membrane removal means of the invention
in the manner shown in FIG. 5B so that the unstretched elastomeric
membrane 27a is separated from the backer sheet 27b. More
particularly, as the membrane 27a is unrolled from roll 74, the
backing film 27b is rolled about a film take-up roll assembly 90
which is positioned proximate turret assembly 76. After being
unrolled from roll 74, the membrane passes through a novel splicing
means generally designated in FIG. 5B by the numeral 92. This
splicing means is of generally conventional construction and
functions to splice together the ends of the elastomeric membranes
which make up the primary and back-up rolls. For example, when roll
74 is exhausted, the end thereof will be stopped at a predetermined
position within the splicing means 92. The turret assembly 76 will
then be rotated so that roll 72 is moved into the feed position
previously occupied by roll 74. With roll 72 in the feed position,
a length of elastomeric membrane is removed from the roll, passed
under film roller 95a, placed upon splicing table 92a, and then
inserted into the splicing means 92 where it will be spliced
together with the inboard end of roll 74. Following the splicing
operation, forward travel of the unstretched membrane can then
continue with the membrane moving forwardly of the apparatus and
with the backing 27b of roll 72 being continuously taken up by
take-up roll assembly 90.
[0052] After the unstretched elastomeric membrane 27a passes
through the splicing means, it is entrained over a guide roller 95b
and under a dancer arm roller 96a which roller forms a part of the
dancer arm assembly 96 of the invention. The dancer arm assembly
comprises, in addition to roller 96a, a dancer arm assembly 98
which pivots about a pivot arm 100 (FIGS. 5B and 7D). The dancer
arm assembly feeds on accumulator assembly 97 which comprises a
plurality of longitudinally, spaced-apart rollers 102 which, along
with dancer arm assembly 98 (FIGS. 5B and 7D), function to monitor
and maintain the proper speed and tension on the membrane 27a as it
advances forwardly of the apparatus toward the second end thereof
71b. Dancer arm assembly 96 and accumulator assembly 97 are
generally of a character known to those skilled in the art and
their operation is well understood by those engaged in continuous
film processing operations.
[0053] As the unstretched membrane 27a continues its forward travel
of the apparatus due to the urging of the membrane removal means,
it will enter the important biaxial stretching means of the
invention which comprises a part of the membrane removal means and
which functions to controllably prestress the membrane to form the
prestressed membrane 27 used in the production of the infusion
devices 14. The biaxial stretching means, which removes the
membrane from the rolls of the support means and controllably
stretches it, can take several forms, but preferably comprises a
tenter apparatus 107 of the general character best seen in FIGS.
5B, 6B, 7B, and 7D of the drawings.
[0054] While a number of different types of tenter apparatus have
been suggested in the past and their design and operation is well
known, a tenter apparatus of the general character described in
German patent 1,504,479 issued to Erwin Kampf can be used in
modified form to accomplish the biaxial stretching step of one form
of the method of the invention.
[0055] As best seen in FIG. 7E, as the unstretched membrane 27a is
unrolled from roll 74, it is introduced into the tenter apparatus
107 in a manner such that the edges of the membrane are securely
gripped by upper and lower anvils of gripping clamps 110. These
gripping clamps are, in turn, operably associated with transversely
spaced-apart elongated endless chain assemblies 112 and 114 which
travel along guide rails 112a and 114a respectively (see also FIG.
6B). As the chains move about rotating sprockets 116 and 118 and
toward differential screws 120 and 122, the gripping clamps urge
the membrane forwardly of the apparatus and diverge outwardly so as
to controllably impart biaxial stretching forces to the membrane
27a causing it to be controllably stretched both transversely and
longitudinally, that is in both an axial direction and a transverse
direction to establish the require strain energy density for the
membrane. More particularly, the biaxial stretching is accomplished
simultaneously in the machine direction orientation (MDO) and in
the transverse direction orientation (TDO) (FIG. 6B). It is to be
understood that the stretching ratios can be precisely tailored to
each axis to provide the desired initial strain energy density and
extension pattern of the distendable membrane. Under certain
circumstances, the extension values for the MDO axis may be
different than the extension values for the TDO axis. It is to be
appreciated, however, that in certain instances, no prestretch of
the membrane will be desired and the tenter frame apparatus will
not be used. As the distendable membrane 27a is stretched to
produce a prestressed membrane 27 of the desired biaxial dimension,
it travels forwardly of the apparatus due to the urging of the
membrane removal means at a uniform controlled first rate of
speed.
[0056] The next step in the method of the invention, is the
important infusion device assembly step wherein the prestressed
membrane is sealably captured between the individual base
components 16 of the base arrays and the individual cover
components 22 of the cover arrays. This unique assembly step is
accomplished without process interruption as the prestressed
membrane travels forwardly of the apparatus in a direction toward
an end take-up roller assembly 127 (FIG. 12) mounted proximate the
second end 71b of the supporting framework 71. Roller assembly 127,
which receives and rolls up the waste membrane that remains after
the devices 14 have been assembled, comprises a part of the
membrane removal means of the invention (FIGS. 5C and 7C). In a
manner next to be described, the assembly of the prestressed
membrane with the base and cover components of the infusion device,
is uniquely accomplished continuously and "on the fly" without any
interruption of the uniform forward travel of the prestressed
membrane.
[0057] The first step in the device assembly step is accomplished
using the first positioning means of the invention which functions
to sequentially position cover arrays of the character shown in
FIG. 1 in close proximity with the novel sealing and bonding means
of the apparatus, the nature of which will presently be described.
As will also be further described in the paragraphs which follow,
at the same time that the cover components of the cover arrays are
being positioned proximate the sealing means, the base arrays of
the character shown in FIG. 2 are being sequentially positioned by
a second positioning means at a location below the moving membrane
and in alignment with the cover arrays.
[0058] The first positioning means of the apparatus of the
invention, which is best shown in FIGS. 5C, 6C, 7C and 9, comprises
a cover array input hopper assembly 130 and a cover array sprue
punch assembly 132, both of which are mounted on a frame 134 that
is superimposed over an open framework 136 which includes an array
supporting table 137 that is reciprocally movable longitudinally of
the framework by a pneumatic assembly generally designated in the
drawings by the numeral 138 which includes operating airlines 138a
which are connected to a suitable source of air under pressure (see
particularly FIG. 9). Pneumatic assembly 138 is of a character well
known to those skilled in the art, and the components thereof are
readily commercially available from sources such as Compact Air
Products of Westminster, S.C.; Robohand, Inc. of Monroe, Conn.; and
Watts Fluid Air, of Kittery, Me. Table 137, which is slidably
disposed internally of frame 136, includes a pair of grid-like
sections 140, each of which is provided with a plurality of
rectangular shaped openings 140a which are sized and arranged to
closely receive the individual cover components 22 of cover arrays
44 of the character shown in FIG. 1. Strategically positioned below
frame 136 is a backing plate 142 which is vertically movable from
the position shown in FIG. 9 to an upraised position wherein the
plate is positioned immediately below frame 136 in a manner to
provide a floor to each of the openings 140a formed in grid
sections 140.
[0059] After the cover arrays 44 have been sequentially removed
from input hopper assembly 130 and have been positioned directly
over grid-like sections 140, table 137 is moved to the left as
viewed in FIG. 9 by suitable pneumatic means 137a (FIG. 5C) to a
position where one of the cover arrays is disposed immediately
below the cover array sprue punch assembly 132. Activation of the
punch assembly will cause the punching head 132a thereof to move
into engagement with and cleanly cut away the sprues 48 of the
cover array. After the sprues are cut away from the first cover
portion, the second cover portion is moved to a location below the
sprue punch assembly and the sprues are similarly cut away from
this array. The sprues which are removed from the cover arrays will
reside on upper cover sprue removal 144 for removal from the
apparatus by vacuum removal means of a conventional nature which
includes a disposal chute 145 (FIG. 8). The vacuum removal means
also comprises cylinders 144a which urge sprue removal 144 toward
chute 145.
[0060] Also forming a part of the first positioning means of the
invention is a cover array shuttle means, generally designated in
FIG. 9 by the numeral 146. This shuttle means includes a shuttle
plate 148 which is reciprocally movable longitudinally of the
apparatus by a conventional type of pneumatic assembly identified
by the numeral 150 (FIG. 9). Plate 148 is also movable by a second
pneumatic lifting assembly 152 from a first lowered position shown
in FIG. 9 to a second upper position wherein the plate resides in a
coplanar relationship with plate 142. After the sprue portions 48
have been removed from a given cover array and with the cover
components resting on plate 142 and entrapped within openings 140a
of one of the grid sections 140, shuttle plate 148 is moved into
close proximity with plate 142 and in a co-planar relationship
therewith. With the plates in this position, a movement of table
137 to the left as viewed in FIG. 9, will cause the cover
components which are entrapped within openings 140a to slide onto
shuttle plate 148. With the cover components thusly positioned on
shuttle plate 148, activation of the pneumatic assembly 150 will
next move the cover components into close proximity with the
sealing means of the invention, the construction of which can best
be seen by referring in FIG. 10. A 16-unit tray, input 153 is shown
in FIGS. 5C and 7C of the drawings to input packaging trays for
containerizing this completed device.
[0061] Referring to FIGS. 5B, 6B, 7B and 10, the sealing means of
the present form of the invention can be seen to comprise a sonic
bonding means 156 which includes a pair of sonic bonding head and
horn assemblies 158 of a conventional construction. Assemblies 158,
which are commercially available from sources such as Forward
Technology Industries of Minneapolis, Minn. and Dukane Corp. of St.
Charles, Ill., are vertically movable relative to a supporting
frame 160 by a plurality of simultaneous pneumatically operated,
cylindrically shaped assemblies 162, which, like assemblies 158,
are also of a character well known to those skilled in the art. It
is important to note that the sonic bonding means 156 is
superimposed directly over the forwardly traveling prestressed
membrane 27 and, by means of a motorized servo electric mechanical
ball screw assembly 164 can be moved synchronously therewith at a
first rate of speed. More specifically, servo electric mechanical
ball screw assembly 164 is connected to and reciprocally moves a
base frame 166 of a character shown in the drawings which functions
to support the sonic bonding head assemblies 158 as well as the
pneumatic cylinders 162.
[0062] As will be discussed in greater detail hereinafter, after
the cover components 22 of the cover arrays 44 have been positioned
on shuttle plate 148, concomitant movement of shuttle plate 148 and
sonic bonding head assemblies 158 will permit the cover components
to be positioned directly below a vacuum capture means associated
with the sonic bonding head assemblies 158. When the cover
components are captured by the capture means, the covers will, of
course, move with the sonic bonding means as it first accelerates
and then travels synchronously with membrane 27 toward the second
end of the apparatus.
[0063] The second positioning means of the invention, which
functions to strategically position a plurality of base arrays 46
below the moving elastomeric membrane 27, here takes the form of a
base array positioning assembly of the character best seen in FIGS.
5B and 11. Referring particularly to FIGS. 11 and 12, this
important positioning assembly can be seen to comprise a lower base
array input hopper 170 which is adapted to store and then
sequentially dispense individual base arrays 46 of the character
illustrated in FIG. 2. Also forming a part of the second
positioning means of the invention is a conveyor assembly 172 which
includes a conveyor belt 174 upon which the individual base arrays
46 are sequentially received from input hopper 170. As the base
arrays are placed in tandem on belt 174 and are carried forwardly
of the apparatus by belt 174, pairs thereof will be sequentially
picked up by pick and place means, shown here as a novel pick up
and place subassembly generally designated in FIG. 11 by the
numeral 176. This pick and place assembly includes a vacuum
operated capture plate 178 for picking up each pair of arrays and
also includes pneumatic means 179 for controllably moving the
capture plate longitudinally of the apparatus at the same rate of
speed as the speed of travel of conveyor belt 174. With this
construction, each of the pairs of base arrays 46 can be
sequentially picked up from the conveyer 174 and expeditiously
transported to novel, centrally disposed lower walking beam shuttle
means generally designated in FIG. 10 by the numeral 180. Shuttle
means 180 includes a deck 182 which supports a pair of vertically
movable base array support platforms 184. Deck 182 along with
platform 184, is moved longitudinally of the apparatus by a
conventional screw assembly generally designated in FIG. 10 by the
numeral 186. In a manner presently to be described, after the base
arrays have been positioned in tandem on the elevator platforms 184
of the central lower walking beam shuttle means, platform 182 will
accelerate and then be moved synchronously with both membrane 127
as it travels forwardly of the apparatus and with the bonding means
of the apparatus as it also travels forwardly of the apparatus at
the same speed of travel as membrane 27. With this novel
arrangement, when the cover components, which are carried by sonic
bonding head assemblies 158 move into alignment with the base
arrays, which are supported on platforms 184, the elevator
platforms will be moved upwardly toward the lower surface of
prestressed membrane 27. At precisely the same time, sonic bonding
assemblies 158, along with the cover components 22 carried thereby,
will move downwardly toward the upper surface of forwardly moving
membrane 27. When the cover components, pressurally engage the
upper surface of the membrane and the base components
simultaneously pressurally engage the lower surface of the
forwardly traveling membrane, the membrane 27 will be cut along a
line defined by a circular-shaped protuberance 187 formed on base
component 16 (FIG. 3). (See also Ser. No. 08/451,520).
Simultaneously, the sonic bonding heads will be energized so as to
sonically bond together the cover components and the base
components with the portions of the prestressed membranes which are
cut away being sealably captured therebetween. In this regard,
protuberances 187, which are generally "V" shaped in cross section,
not only cut the membrane, but also act as energy directors to
facilitate the sonic bonding of the cover and base components.
[0064] Accomplishment of the method of the invention for continuous
assembly of the infusion devices 14 can be best understood by
referring to FIGS. 12 through 15. Referring particularly to FIG.
12, the various cooperating mechanisms of the component assembly
means of the invention are shown in a starting position at which
the first step in the component assembly method of the invention
can be commenced. More particularly, as shown in FIG. 12, shuttle
plate 148 of the first positioning means of the invention is empty
and ready to receive cover components from plate 142 of the sprue
removal means. Similarly, the elevator platforms 184 of shuttle
means 180 are empty and ready to receive base component arrays
which have been dispensed from base array hopper 170 onto the
surface of conveyor belt 174. Turning to FIG. 13, the phantom lines
of this drawing show the cover components which have been
transferred from transfer plate 142 to shuttle plate 148 by
movement of table 137 to the left. The solid lines reflect the
movement of platform 148 into a position directly below and in
close proximity with sonic bonding head assemblies 158. With the
cover components in this position, they are ready for capture by
the vacuum capture means carried by the sonic bonding apparatus
158. The phantom lines in the lower left hand portion of FIG. 13
show the pickup and place subassembly 176 in position over a pair
of base arrays which have been taken from hopper assembly 170 and
positioned in tandem on conveyor belt 174. Also shown in phantom
lines at the lower right of the FIG. 13 is the centrally disposed
lower walking beam shuttle means of the invention with the
previously assembled infusion devices 14 having been removed
therefrom by the product removal shuttle or product pick up and
place subassembly of the apparatus of the invention which is
generally designated in FIG. 13 by the numeral 190. The solid lines
in FIG. 13 show the central lower walking beam shuttle assembly 180
located in a position ready to receive the base arrays which have
been picked up and transferred by the pickup and place subassembly
176, which is also shown in solid lines.
[0065] Turning to FIG. 14, the important sonic bonding step of the
method is there illustrated. More particularly, the sonic bonding
head assemblies 158 which carry the cover components are shown in a
position in alignment with the base components carried by the
elevator platforms 184 and moved upwardly into close proximity with
the lower surface of membrane 27. It is to be noted that this step
has been accomplished with the sonic bonding assemblies 158 and the
elevator platforms 184 being first accelerated and then moved
synchronously forwardly of the apparatus at the same rate of speed
as and synchronously with membrane 27. As previously mentioned, as
the cover components and the base components come into pressural
engagement with the elastomeric membrane 27, the membrane will be
cut along the circular shaped energy directors 187 provided on the
upper surface of the base components. At this same instant in time,
the base components and cover components will be bonded together
with the cut portion of the membrane sealably captured
therebetween.
[0066] Turning to FIG. 15, which illustrates the post assembly
position of the various components of the component assembly means,
it is to be noted that the bonding head assemblies have once again
been elevated to their original starting position shown in FIG. 12
and similarly, the elevator platforms 184 of the lower walking beam
central shuttle means have been lowered to their original starting
position shown in FIGS. 12 and 13. Disposed on the upper surfaces
of the elevator platform 184 are the sealably interconnected device
arrays 54 which are of the character shown in FIG. 3A. As indicated
by the arrows in FIG. 15, during this post assembly step, the
central shuttle means 180 is moving forwardly of the apparatus
while the final product pickup and place assembly 190 is moving in
the opposite direction due to the urging of pneumatic operating
means 190a of conventional construction. This movement of the
pickup and place assembly 190, as shown by the arrows of FIG. 15,
will continue until the finished product arrays 54 disposed on
platforms 184 are directly below the pickup and placement assembly
190. At this instant in time, the vacuum plate 190b of the pickup
and placement assembly 190 will be lowered and the finished product
arrays 54 will be captured. This done, travel of the final product
pickup and placement assembly 190 will be reversed so that the
final product arrays can be superimposed over and strategically
placed upon a final product conveyor 194 of the character best seen
in FIG. 16. As shown in FIG. 16, the final product arrays 54 are
then carried by conveyor 194 to a final product lower base sprue
removal station 197 (FIGS. 5C, 7C, and 16) where the sprues 50,
which interconnect the assembled devices 14 are cut away. Following
this sprue removal process, the finished components are transported
to the final product packaging station where they are packaged for
shipment and are removed from the apparatus (FIG. 16).
[0067] The sprue cutting operation, wherein sprues 50 are removed
from the final product arrays, is accomplished by a sprue cutting
apparatus of generally conventional construction. Similarly, the
packaging step is accomplished using plastic thermo form tray
packaging apparatus of a character well known to those skilled in
the art which includes packaging the final product in the vacuum
formed tray using a thermo sealing film material 199 which is
dispensed from a roll of sealing material 199a (FIGS. 5C, 7C, and
16). Because these processes are well understood by those skilled
in the art, the details of the final sprue removal process and of
the packaging process will not be discussed in detail.
[0068] It is to be understood that the various operating
subassemblies of the character described in the preceding
paragraphs are controllably operated by the control means shown in
FIGS. 5A, 6A and 7A and generally designated as 60.
[0069] Having now described the invention in detail in accordance
with the requirements of the patent statutes, those skilled in this
art will have no difficulty in making changes and modifications in
the individual parts or their relative assembly in order to meet
specific requirements or conditions. Such changes and modifications
may be made without departing from the scope and spirit of the
invention, as set forth in the following claims.
* * * * *